How does the ethical review process work in Lithuania and which are the designated ethics committees?
Following the Law on Ethics of Biomedical Research, there are two types of institutions with responsibility for biomedical research evaluation in Lithuania. The Lithuanian Bioethics Committee represents the first type of institution, namely, the national one. The second type of institution is represented by the Regional Biomedical Research Ethics Committees. Biomedical research in Lithuania may be performed if approval has been received from the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee.
The Lithuanian Bioethics Committee
The Law on Ethics of Biomedical Research mandate the establishment of the Lithuanian Bioethics Committee and its competence:
1. The Lithuanian Bioethics Committee shall be established and its composition and regulations shall be approved by the Ministry of Health.
2. The Lithuanian Bioethics Committee shall address the following areas:
- analyse problems of bioethics and consult central and local authorities, agencies and organizations on these issues, submit conclusions and proposals relating to laws and other legal acts regulating problems of bioethics;
- annually report to the Ministry of Health about its own activities and make proposals on how to address bioethical problems;
- review whether individual and public health care is in conformity with the requirements of medical ethics and monitor compliance of legal persons with the requirements of bioethics;
- provide methodological assistance and consult medical ethics committees of health care establishments on the issues relating to their activities;
- within the scope of their competence represent Lithuania in international organisations;
- perform other functions provided for in its regulations;
- issue approvals for conducting biomedical research and undertake the ethical review of research and monitoring of the activities of Regional Biomedical Research Ethics committees;
- the Lithuanian Bioethics Committee shall keep a record of biomedical research, collect, store and provide information about the research, whilst ensuring the protection of confidential information. It shall also design and approve standard forms related to the ethical review of research protocols.
Multicenter biomedical research projects
Should biomedical research be carried out in more than one region, the Lithuanian Bioethics Committee shall issue the approval. In this case, the Lithuanian Bioethics Committee shall decide upon the necessity to obtain the approval of the Regional Biomedical Research Ethics Committees of the regions, where biomedical research will be carried out. The Lithuanian Bioethics Committee shall inform the Regional Biomedical Research Ethics Committees about biomedical research to be carried out in their respective regions.
Regional Biomedical Research Ethics Committees
Regional Biomedical Research Ethics Committees are established in the counties having universities and are proportionally composed of representatives of the degree-holding academic community, health care specialists and the general public. The quotas of representation in the committees, the number of committee members and composition of the committees, the territory of their jurisdiction shall be established by the Lithuanian Bioethics Committee which also approves standard operating procedures for the committees.
Scope of biomedical research
The Law establishes a rather broad understanding of biomedical research by defining it as “a verification of hypotheses of biomedicine by methods of scientific investigation and the development of knowledge about characteristics of human health.”
The procedure for issuing approvals is regulated by Ministry of Health Decree (entitled “Procedure to issue approvals to conduct biomedical research”, October 23, 2000, No. 570). It deals with the procedure of approvals and annulments of approvals, the procedure for examination of complaints and the procedure for payment of the fees for biomedical research expert examination.
- To be given an approval, the sponsor of a biomedical research and/or the principal investigator, shall submit an application and relevant documents to the Lithuanian Bioethics Committee and, in the cases established by this Procedure, to the Regional Biomedical Research Ethics Committee.
- Approvals to conduct clinical research of medicinal products shall be issued upon recommendation of the State Drug Control Agency.
- Approvals to conduct clinical research on medical devices shall be issued upon recommendation by the State Health Care Accreditation Agency.
- When the Lithuanian Bioethics Committee issues approval, the decision to issue approval shall be discussed and approved in a session held by a group of biomedical research experts of the Lithuanian Bioethics Committee.
- Applications and documents shall be examined by the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee, and an approval shall be issued not later than within 45 calendar days after registration of the application and pertinent documents, after the payment of all the fees for biomedical research expert examination, except in the cases laid down in the pertinent laws.